Defining the Sympathetic Skin Response of Migraineurs in the Facial Area

• Conditions: Migraine Disorders
• Interventions: Other: Pain stimulation; Other: Visual stimulation; Other: Auditory stimulation; Other: Mental stress

• Registration Number: NCT03772860
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

The aim of this study is to define the sympathetic skin response of migraineurs in the facial area. This will be achieved by exposing healthy volunteers and migraine patients to various stress stimuli (pain, visual stimulation, auditory stimulation and a mathematical challenge), and recording sympathetic skin response in the facial area.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-12
• Study Start: 2018-12
• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-10
• Last Update Submitted: 2018-12-10
• Study First Posted: 2018-12-11
• Last Update Posted: 2018-12-11
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Healthy volunteers with no history of any kind of recurrent headache
• Migraine patients according to ICH3 criteria
• Migraine patients with more than 1 attack per month

Exclusion Criteria

• Patients with other heart or neurologic diseases
• Patients with hearing or visual decline
• Patients taking medication that effects the sympathetic system (except those taking beta blockers for migraine treatment)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Pain stimulation	Healthy volunteers will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress
Healthy volunteers	Auditory stimulation	Healthy volunteers will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress
Right headache	Auditory stimulation	Migraine patients with mostly right sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress
Healthy volunteers	Visual stimulation	Healthy volunteers will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress
Left headache	Auditory stimulation	Migraine patients with mostly left sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress
Left headache	Mental stress	Migraine patients with mostly left sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress
Healthy volunteers	Mental stress	Healthy volunteers will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress
Left headache	Pain stimulation	Migraine patients with mostly left sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress
Right headache	Visual stimulation	Migraine patients with mostly right sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress
Bilateral headache	Pain stimulation	Migraine patients without a dominant side headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress
Bilateral headache	Visual stimulation	Migraine patients without a dominant side headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress
Bilateral headache	Auditory stimulation	Migraine patients without a dominant side headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress
Left headache	Visual stimulation	Migraine patients with mostly left sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress
Right headache	Pain stimulation	Migraine patients with mostly right sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress
Bilateral headache	Mental stress	Migraine patients without a dominant side headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress
Right headache	Mental stress	Migraine patients with mostly right sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress

Primary Outcome Measures

Name	Time	Method
Defining sympathetic skin response in migraineurs	One year	Outcome will be presented as mean sympathetic response values for all the different stimuli and then separately for each stimuli

Secondary Outcome Measures

Name	Time	Method
Defining differences between sympathetic skin response in migraineurs	One year	Outcome will be presented as mean sympathetic response values for all the different stimuli and then separately for each stimuli

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel